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Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 430 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Highlands Oncology Group - Springdale /ID# 277132
Springdale, Arkansas, United States
Cancer Care Centers of Brevard- Rockledge /ID# 277853
Rockledge, Florida, United States
HealthPartners Cancer Research Center /ID# 277339
Saint Louis Park, Minnesota, United States
Nho - Revive Research Institute /ID# 277569
Lincoln, Nebraska, United States
Astera Cancer Care /ID# 277570
East Brunswick, New Jersey, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, Tennessee, United States
SCRI Oncology Partners /ID# 276959
Nashville, Tennessee, United States
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, Washington, United States
Canberra Hospital /ID# 277166
Garran, Australian Capital Territory, Australia
St George Hospital /ID# 277168
Kogarah, New South Wales, Australia
Start Date
December 10, 2025
Primary Completion Date
September 1, 2030
Completion Date
September 1, 2030
Last Updated
March 11, 2026
430
ESTIMATED participants
Telisotuzumab Adizutecan
DRUG
Standard of Care
DRUG
Lead Sponsor
AbbVie
NCT06305754
NCT07190248
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07100080